Trial record 2 of 510 for:    weight loss AND (woman OR women OR female)

Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women, Also Known as Women Weigh-in for Wellness

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carol H. Pullen, BSN MSN EdD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01307644
First received: March 1, 2011
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.


Condition Intervention
Overweight and Obese by BMI
Behavioral: Web based weight loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare the effectiveness of improving physical activity and healthy eating via a) interactive website only, b) interactive website plus a peer-led online support group, and c) interactive website plus professional weight loss counseling via e-mail in facilitating initial weight loss (baseline to 6 months).


Secondary Outcome Measures:
  • Weight Maintenance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Compare the effectiveness of improving physical activity and healthy eating via a) interactive website only, b) interactive website plus a peer-led online support group, and c) interactive website plus professional weight loss counseling via e-mail in facilitating maintenance of weight loss from month 7 to month 30.


Enrollment: 301
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Website plus professional counseling
A professional counselor who is experienced in healthy eating and activity to accomplish weight loss will review women's eating, activity and weight logs and goals on the web site and send e-mail feedback once a week. The women can e-mail questions and the counselor will respond. If a woman has not posted, the counselor will send one reminder e-mail. The e-mail process will follow the 5A's Model for Behavioral Counseling (assess, advise, agree, assist, and arrange) that was adapted for this study.
Behavioral: Web based weight loss
Using interactive website only, website plus a peer-led online support group, or website plus professional behavioral counseling to facilitate weight loss and maintenance, increase healthy eating, physical activity, and 4 behaviors from HPM
Experimental: Website plus peer support group
A peer leader in the age range of the women, who has been successful in losing weight and maintaining that loss, will facilitate the asynchronous discussion group. The primary purpose of this group is to provide support, increase self-efficacy (role modeling by successful women and leader) and discuss progress toward goals. The peer leader will post a message once a week and participate in the discussion with the women.
Behavioral: Web based weight loss
Using interactive website only, website plus a peer-led online support group, or website plus professional behavioral counseling to facilitate weight loss and maintenance, increase healthy eating, physical activity, and 4 behaviors from HPM
Active Comparator: Interactive Internet Only
An interactive website will provide a lifestyle change plan for healthy eating and activity to accomplish weight loss.
Behavioral: Web based weight loss
Using interactive website only, website plus a peer-led online support group, or website plus professional behavioral counseling to facilitate weight loss and maintenance, increase healthy eating, physical activity, and 4 behaviors from HPM

Detailed Description:

According to the National Institutes of Health, "obesity is one of the most daunting health challenges of the 21st century". Approximately 2/3 of all adults are overweight or obese. Efforts to abate the growing prevalence of obesity have not been successful. The Strategic Plan for NIH Obesity Research proposes preventing and treating obesity through lifestyle modification. The purpose of this study is to evaluate the effectiveness of a theory-based intervention framed within the Health Promotion Model (HPM) in facilitating weight loss and maintenance through promotion of healthy eating and physical activity among an underserved, vulnerable population of overweight or obese rural women aged 40-69. During these years, women experience increases in peri- and post-menopausal health risks that are magnified if they are overweight or obese. Weight loss will reduce risks and enhance functional status as they age. Maintenance of weight loss will be emphasized. The Internet offers a way to reach isolated rural women who have limited options for weight loss guidance. PUBLIC HEALTH RELEVANCE: Obesity is recognized as a major and growing public health problem. While many weight loss programs have been successful in the short term, they have not been successful in helping to maintain weight loss.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women aged 40-69
  • overweight or Class I & II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance
  • state a commitment to losing weight
  • speak and read English
  • able to communicate over the telephone
  • able to use a computer with minimal assistance and complete electronic forms and surveys
  • have access to and are able to access the Internet
  • commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention
  • have or are willing to obtain an email account
  • have access to a DVD player
  • able to walk without an assistive device
  • answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active

Exclusion Criteria:

  • diagnosed with Type 1 diabetes
  • diagnosed with Type 2 diabetes and require insulin
  • ≥ 10% weight loss in last six months
  • enrolled in a weight loss management program
  • enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation
  • taking medications that affect weight loss or weight gain
  • other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307644

Locations
United States, Nebraska
Central Community College
Columbus, Nebraska, United States, 68602-1027
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Carol H. Pullen, EdD, RN University of Nebraska Medical Center College of Nursing
  More Information

No publications provided by University of Nebraska

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carol H. Pullen, BSN MSN EdD, Dr. Carol Pullen, University of Nebraska
ClinicalTrials.gov Identifier: NCT01307644     History of Changes
Other Study ID Numbers: 237-10-FB, 1R01NR010589-01A2
Study First Received: March 1, 2011
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Overweight
Obesity
Rural Health
Weight Loss
Weight Maintenance
Rural Middle Aged and Older Women
Web Intervention Weight Loss
Class I, II, & III obese (BMI 28 to 45)

Additional relevant MeSH terms:
Weight Loss
Overweight
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014